Life Force for Risk Reduction Behavior

Overseen By Life Force Study

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Uniformed Services University of the Health Sciences

Disqualifiers: Leaving service, PCS, deployment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

2400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a skills-based training program designed to reduce harmful and risky behaviors while boosting mental toughness among active-duty Soldiers. Participants will either join the Life Force program, which includes five group training sessions, or be part of a control group receiving standard care. The researchers aim to assess the training's effectiveness and identify who benefits most. Active-duty Soldiers stationed at Fort Hood, TX, who do not plan to leave the service soon, might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the well-being of fellow Soldiers.

What prior data suggests that this training is safe for active-duty Soldiers?

Research shows that the Life Force program aims to help soldiers reduce harmful behaviors and build mental strength. Past studies on similar programs have found a reduction in risky behaviors, such as suicidal actions, among veterans. These studies have reported no major safety issues.

The Life Force program includes group sessions focused on teaching skills, which are generally safe. Participants learn to manage stress and make better decisions. Since the program does not involve medication or medical treatments, physical side effects are unlikely.

In summary, based on past research, the Life Force program appears well-tolerated. Participation mainly involves learning and practicing skills, suggesting a low risk of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Life Force program because it offers a fresh approach to reducing risky behaviors among active duty Soldiers. Unlike traditional methods that might focus on individual therapy or medication, Life Force is a group-based skills training program. It uses evidence-based strategies specifically designed to boost Mental Toughness, aiming to empower Soldiers with practical skills to navigate stress and avoid harmful behaviors. This innovative focus on group dynamics and skills training sets it apart from standard care, which typically involves follow-up assessments without such targeted intervention.

What evidence suggests that the Life Force program is effective for reducing high-risk behaviors in Soldiers?

Research shows that skills-based training programs, such as the Life Force program tested in this trial, can help reduce harmful behaviors. Participants will receive either the Life Force program or standard care. Studies have found that similar group training programs have lowered suicidal behavior in Veterans. By focusing on building mental strength, these programs have led to better mental health. People who complete these programs often feel less hopeless and depressed. This suggests that the Life Force program could help active-duty Soldiers reduce risky behaviors and improve mental resilience. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for active-duty soldiers aged 18 or older who are stationed at Fort Hood, TX. It aims to help them develop mental toughness and reduce harmful behaviors.

Inclusion Criteria

Active duty Soldiers in the regular Army

Stationed at Fort Hood, TX

I am 18 years old or older.

Exclusion Criteria

Soldiers having a planned permanent change in station (PCS) or deployment within 12 months of the baseline assessment

I plan to leave active duty within the next 12 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants complete a 15-20 minute baseline survey to assess initial conditions

1 day

Training

Participants in the Life Force program complete 5 group-based skills training sessions

5 weeks

5 sessions (in-person)

Follow-up

Participants complete follow-up surveys at 6 and 12 months to assess outcomes

12 months

2 surveys (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Life Force

Trial Overview

The study tests 'Life Force,' a group-based training program designed to increase resilience among soldiers. Participants will be compared with a control group over surveys taken at baseline, 6 months, and 12 months.

How Is the Trial Designed?

Group I: Life Force program Experimental Treatment 1 Intervention

The Life Force program is a 5-session, group-based, skills training program tailored specifically for active duty Soldiers. The program uses evidence-based strategies to mitigate harmful and high-risk behaviors and promote Mental Toughness.

Group II: Control Active Control 1 Intervention

Standard of care with 6- and 12-month follow up assessments.

Who Is Running the Clinical Trial?

Uniformed Services University of the Health Sciences

Lead Sponsor

Trials

130

Recruited

91,100+

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborator

Trials

103

Recruited

94,300+

Defense Health Agency

Collaborator

Trials

3

Recruited

750+

Harvard University

Collaborator

Trials

237

Recruited

588,000+

Regents of the University of Michigan

Collaborator

Trials

3

Recruited

2,200+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07050238

Evaluation of a Group-based, Skills Training for Increasing ...

The goal of the Life Force study is to (1) evaluate the efficacy of targeted, skills-based training for enhancing mental toughness and mitigating harmful and ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7000793/

Group (“Project Life Force”) versus individual suicide safety ...

The primary outcome variable is the incidence of suicidal behavior, during follow-up, established using a rigorous, multi-method assessment.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03653637

Group ("Project Life Force") vs. Individual Suicide Safety ...

Research suggests creation of the SSP is effective; one study found that Veterans who present to an emergency room show decreased suicide behavior after ...

4.

mirecc.va.gov

mirecc.va.gov/visn2/clinical/clinical.asp

VISN 2 MIRECC Clinical Core

The Clinical Core of VISN 2 MIRECC is dedicated to improving mental health outcomes for Veterans through innovative clinical services, expert consultation,

5.

grantome.com

grantome.com/grant/NIH/I01-CX001705-03

Group (?Project Life Force?) vs. Individual Suicide Safety ...

The primary outcome is suicidal behavior with secondary outcomes of hopelessness, depression and treatment utilization. Funding Agency. Agency: National ...

6.

trial.medpath.com

trial.medpath.com/clinical-trial/267635912292a506/nct03653637-project-life-force-suicide-safety-planning

Group ("Project Life Force") vs. Individual Suicide Safety ...

Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The main objective of this RCT is to examine if Veterans who are ...